目的:美国食品和药物管理局已将身体功能(PF)确定为癌症临床试验中患者报告的核心结果(PRO)。这项研究的目的是确定成人癌症人群中的PFPRO措施(PROMs),并根据每种措施中涵盖的内容(PF的方面)对PROMs进行分类。
方法:作为身体功能研究(PROPS)研究计划的患者报告的一部分,我们进行了有针对性的文献综述,以确定可用于临床试验的PROM,从患者角度评估PF.接下来,我们召集了一个顾问小组进行了修改,reactive,Delphi研究就审查中确定的PROM评估的PF方面达成共识。面板参与“卡片分类”活动,按PF方面对PROM项目进行分类。当80%的小组成员同意每个PROM项目至少测量一个方面时,达成了共识。
结果:文献综述确定了13个符合纳入标准的PROM。在德尔菲研究中确定了PF的八个方面进行分类:能力,完成,困难,限制,质量,频率,打扰,和满意度。通过两轮,小组对所呈现的每个PRO项目的概念方法进行了记录和分类。最普遍的PF方面是能力,困难,和限制。
结论:按PF方面对PFPROM进行分类将促进关于每个PROM中表示的PF方面的更一致的沟通,帮助研究人员优先考虑纳入癌症临床试验的措施。
OBJECTIVE: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure.
METHODS: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a \"card sort\" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item.
RESULTS: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation.
CONCLUSIONS: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials.